Pierre Fabre Laboratories Receive Positive CHMP Opinion for OBGEMSA(vibegron) in Overactive Bladder Syndrome
Pierre Fabre Laboratories Receive Positive CHMP Opinion for OBGEMSA(vibegron) in Overactive Bladder Syndrome
CASTRES, France, April 26, 2024 /PRNewswire/ -- Pierre Fabre Laboratories announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of OBGEMSA (vibegron under the international non-proprietary name) for the symptomatic treatment of adult patients with overactive bladder syndrome (OAB). Pierre Fabre Laboratories acquired an exclusive license from Urovant Sciences to register and commercialize vibegron in the European Economic Area in 2022. OBGEMSA is a trademark owned by Urovant Sciences GmbH.
法國卡斯特爾，2024年4月26日 /PRNewswire/ — 皮爾法伯實驗室宣佈，歐洲藥品管理局（EMA）人用藥品委員會（CHMP）已通過一項積極意見，建議批准OBGEMSA（國際非專利名稱的vibegron）對成年膀胱過度活動綜合徵（OAB）患者進行對症治療。皮爾法伯實驗室獲得了Urovant Sciences的獨家許可，將於2022年在歐洲經濟區註冊和商業化vibegron。OBGEMSA 是 Urovant Sciences GmbH 擁有的商標。
The CHMP recommendation will now be reviewed by the European Commission (EC), which may decide on the marketing authorisation (MA) for OBGEMSA (vibegron). The decision will then be applicable to all member states of the European Union as well as to Iceland, Liechtenstein and Norway.
CHMP的建議現在將由歐盟委員會（EC）審查，歐盟委員會可能會決定OBGEMSA（vibegron）的上市許可（MA）。然後，該決定將適用於歐盟的所有成員國以及冰島、列支敦士登和挪威。
" We are very pleased to have received this positive opinion from the CHMP for OBGEMSA. If approved, this innovative therapeutic solution has the potential to help patients suffering from overactive bladder, a condition that is very debilitating in daily life. We have been working in the field of urology for more than 40 years and OBGEMSA is proof of our determination to continue our development in this area." said Eric DUCOURNAU, CEO of Pierre Fabre Laboratories.
“ 我們很高興收到CHMP對OBGEMSA的積極評價。如果獲得批准，這種創新的治療解決方案有可能幫助患有膀胱過度活動症的患者，這種疾病在日常生活中非常虛弱。我們在泌尿外科領域工作了40多年，OBGEMSA證明了我們繼續在該領域發展的決心。” 皮爾法伯實驗室首席執行官埃裏克·杜庫爾瑙說。
The CHMP positive opinion is based on positive data from two Phase 3 pivotal, randomized, multicenter and double-blind studies in patients with symptoms of overactive bladder. Study RVT-901-3003 assessed the efficacy, tolerability and safety at 12 weeks of vibegron (at a dose of 75 mg/daily) compared to placebo and tolterodine (as positive control). Its extension, Study RVT-901-3004, assessed the long-term safety, tolerability and efficacy of vibegron at 52 weeks versus tolterodine. In these studies, vibegron, as a new beta-3 adrenergic receptor (ß3 AR) agonist, demonstrated a favourable risk-benefit profile in the symptomatic treatment of urgency, increased micturition and urge urinary incontinence (UUI) that may occur in patients with OAB syndrome.
CHMP的積極意見基於兩項針對膀胱過度活動症狀患者的3期關鍵、隨機、多中心和雙盲研究的陽性數據。RVT-901-3003 研究評估了 vibegron 12 周（每日劑量 75 mg）與安慰劑和托特羅定（作爲陽性對照組）相比的療效、耐受性和安全性。其延伸部分，即 RVT-901-3004 研究，評估了 vibegron 在 52 周時與托特羅定對比的長期安全性、耐受性和療效。在這些研究中，vibegron作爲一種新的β-3腎上腺素能受體（β3 AR）激動劑，在對症治療OAB綜合徵患者可能發生的緊急、尿量增加和急迫性尿失禁（UUI）方面顯示出良好的風險效益特徵。
The CHMP positive opinion is also supported by clinical data from the study URO-901-1001, a randomized, Phase 1, double-blind, placebo-controlled, parallel-group study in subjects with OAB, designed to study the effect of vibegron (at a dose of 75 mg daily or placebo once daily) for a duration of 28 days at steady state on ambulatory blood pressure (BP) and heart rate (HR). Results from this study confirm that vibegron 75 mg had no statistically significant or clinically meaningful effects on Blood Pressure or Heart Rate in patients with symptoms of OAB.
CHMP的積極觀點也得到了研究 URO-901-1001 的臨床數據的支持，該研究是一項針對OAB受試者的隨機1期雙盲、安慰劑對照的平行組研究，旨在研究vibegron（每日劑量爲75 mg或每天一次安慰劑）在穩定狀態下持續28天對動態血壓（BP）和心率（HR）的影響。這項研究的結果證實，vibegron 75 mg對有OAB症狀的患者的血壓或心率沒有統計學上顯著或臨床上有意義的影響。
About overactive bladder (OAB)
The OAB syndrome is clinically characterized by urinary urgency (i.e. a sudden compelling desire to void that is difficult to defer), with or without urge urinary incontinence UUI, and usually accompanied by urinary frequency and nocturia in the absence of urinary tract infection or other obvious pathology. UUI is the involuntary loss of urine accompanied by urgency. UUI is distinguished from stress urinary incontinence, which is the involuntary loss of urine on effort or physical exertion (e.g., sporting activities), or on sneezing or coughing. When both components are present, the classification is mixed urinary incontinence, with either urgency or stress specified as the predominant component. From a pathophysiological perspective, the OAB symptom complex is suggestive of detrusor overactivity, which may be intrinsic or may be secondary to neurological conditions such as stroke or spinal cord injury.
關於膀胱過度活躍 (OAB)
OAB 綜合徵的臨床特徵是尿急（即突然強烈的排尿慾望，難以推遲），伴有或沒有急迫性尿失禁 UUI，在沒有尿路感染或其他明顯病理的情況下，通常伴有尿頻和夜尿症。UUI 是指伴有緊急情況的非自願尿液流失。UUI 與壓力性尿失禁有區別，壓力性尿失禁是指因努力或體力消耗（例如體育活動）或打噴嚏或咳嗽而非自願流失尿液。當兩種成分都存在時，分類爲混合性尿失禁，尿急或壓力爲主要成分。從病理生理學的角度來看，OAB 症狀複合體提示逼尿劑過度活躍，這可能是內在的，也可能是繼發於中風或脊髓損傷等神經系統疾病。
About vibegron
Vibegron is a novel, potent, and selective human beta-3 adrenergic receptor (β3-AR) agonist. Beta receptors are found throughout the body, but β3-ARs are predominantly found on human detrusor smooth muscle. β3-ARs agonists bind to and activate beta-3 receptors on the detrusor muscle, leading to relaxation of the detrusor muscle to increase vesical capacity and to reduce OAB symptoms. Vibegron received approval in the U.S. in December 2020 (at 75 mg once daily, under the tradename GEMTESA) for the treatment of OAB with symptoms of UUI, urgency, and urinary frequency in adults and in Japan and in the Republic of Korea, respectively in September 2018 and in October 2022 (at 50 mg once daily, under the tradename BEOVA) for the treatment of OAB in adults. GEMTESA is a trademark of Urovant Sciences GmbH, and registered in the U.S., and in other countries. In the U.S., GEMTESA is marketed by Sumitomo Pharma America, Inc.
關於 vibegron
Vibegron 是一種新型、有效的選擇性人類 β-3 腎上腺素受體 (β3-AR) 激動劑。β受體存在於全身，但β3-ARS主要存在於人體逼尿器平滑肌中。β3-ARS激動劑結合並激活逼尿肌上的β-3受體，導致逼尿肌鬆弛以增加膀胱容量並減輕OAB症狀。Vibegron於2020年12月在美國獲得批准（每天一次75毫克，商品名爲GEMTESA），用於治療成人有UUI、尿急和尿頻症狀的OAB，並於2018年9月和2022年10月（每天一次50毫克，商品名爲BEOVA）獲得批准，用於治療成人OAB。GEMTESA 是 Urovant Sciences GmbH 的商標，在美國和其他國家註冊。在美國，GEMTESA由住友製藥美國公司銷售。
About Pierre Fabre Laboratories
For more information, visit , @PierreFabreGroup.
關於皮爾法伯實驗室
欲了解更多信息，請訪問 ， @PierreFabreGroup。
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